U.S. fights efforts to expand access to AIDS drugs

Industry protests as poorer nations seek local licensing

April 30, 1999|By CHICAGO TRIBUNE

WASHINGTON -- Though the AIDS epidemic is taking its steepest toll in some of the poorest regions of the world, the U.S. government and the U.S. pharmaceutical industry are fighting efforts to make the latest lifesaving drugs more widely available in those countries.

The battle pits the drug companies' campaign to maintain exclusive control of the manufacture and marketing of their patented medicines against the desire by some countries to issue licenses for the drugs to local companies so that they can make generic versions that are more affordable to their impoverished citizens.

Last year, President Nelson Mandela raised hopes among South Africa's growing number of AIDS patients when he signed a law designed to make more affordable some of the new drugs that slow the progress of the disease.

Under the law, the South African government could begin issuing licenses to local companies to manufacture low-cost generic versions of patented anti-AIDS medicines. The World Trade Organization guards intellectual property rights among its member nations, but its global rules of trade allow for what is known as "compulsory licensing" to combat a national emergency.

In a country with more than 3 million human immunodeficiency virus cases and where one-quarter of pregnant mothers in the poorest provinces are HIV-positive, the new South African compulsory-licensing law would seem to meet the World Trade Organization's national emergency guidelines for compulsory licensing.

The South African law was designed to "ensure through either global market forces or local market forces that medicines become affordable for the people of South Africa," said Ian Roberts, special assistant to the government's health minister.

The law angered the U.S. pharmaceutical industry, which fears that widespread licensing of its products would lead to a global "gray market" in low-priced drugs and undermine its profits and incentives for researching the latest pharmaceuticals. It pressed its allies in the U.S. government to swing into action against the South African law.

South Africa pressured

They quickly complied. Rep. Rodney Frelinghuysen, a New Jersey Republican, inserted a rider in October's appropriations bill that temporarily cut off foreign aid to South Africa as a way of pressuring the State Department to take more forceful actions against the law.

U.S. Trade Representative Charlene Barshefsky, saying the South African law was too broad and might be applied to other medicines, denied South Africa special tariff breaks on its exports to the United States in an effort to pressure the government to repeal the law. And Vice President Al Gore raised the issue when he visited Mandela this year.

But South Africa has refused to back down. That has prompted dozens of big U.S. and European pharmaceutical companies to challenge the law in a South African court, where they recently won a temporary injunction.

"In the West, companies are killing themselves to come up with the next Viagra, while the developing world doesn't have access to basic medicines," said Nathan Ford, who works in the London office of Doctors Without Borders. "In many of these countries, tuberculosis and AIDS drugs are priced at Western market levels."

The pharmaceutical industry considers compulsory licensing "a form of patent piracy," said Thomas Bombelles of the Pharmaceutical Research and Manufacturers Association, the industry trade group. "It's stealing," he said.

Joe Papovich, assistant U.S. trade representative for intellectual property issues, said, "We're negative towards compulsory licensing. We think companies that have the rights to new inventions should have the right to market them the way they want."

Physicians at not-for-profit groups who labor in poor countries where clinics have been inundated with AIDS patients are using the compulsory-licensing issue to pressure the global pharmaceutical industry to come up with ways of making its high-priced wonder drugs available where they are needed most.

Those groups say the issues surrounding the affordability of AIDS drugs apply equally to treatments for malaria, tuberculosis and meningitis, which kill millions of people each year in the less-developed world.

The double- and triple-drug therapies that keep HIV-positive people from developing full-blown AIDS cost more than $10,000 a year in the advanced industrial world and are virtually unheard of in poor countries. Drugs for treating the chronic infections that kill AIDS sufferers can cost $100 to $150 a month in developing countries, more than the average worker's monthly salary.

For example, AZT, a drug made by Glaxo-Wellcome that has proved effective in helping HIV-positive pregnant women inhibit transmission of the virus to their babies, costs about $240 a month in South Africa. Indian drug companies manufacture a generic version of the drug and provide it for $48 a month.

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